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DocumentStudy Data Tabulation Model
Short NameSDTM
Version1.4
ReleasedNovember 2013



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The Study Data Tabulation Model (SDTMIG) v1.4 was published in November 2013.


Note

This page lists errata for an older version of SDTM.

This page contains the working list of errata for the final version 1.4 of the SDTM.

Study Data Tabulation Model
 

  • Page 27 / Section 3.2.2, Trial Arms: In the description for ARMCD, the second sentence, "If the timing of visits for a trial does not depend on which ARM a subject is in, then ARMCD should be null," should be removed.
  • Page 14 / Section 2.2.3, The Findings Observation Class: In the description for --DISTR,  'Examples: "FOCAL", "MULTIFOCAL", "DIFFUSE", "FOCAL", "MULTIFOCAL"' should be changed to 'Examples: "FOCAL", "MULTIFOCAL", "DIFFUSE"'.